BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2162794 · Received July 15, 2011

    Report

    Report Number
    6000001-2011-11989
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. A LEAK TEST WAS PERFORMED ON THE UNIT BY FILLING THE RESERVOIR WITH COLORED WATER. DURING FILL, LEAKAGE WAS NOTED AT THE JUNCTION OF THE TUBING AND THE MICROBORE. VISUAL EXAMINATION OF THE UNIT OBSERVED A BONDING GAP AT THE MICROBORE-Y AND TUBING BOND. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFECT: BONDING METHOD (LACK OF TWISTING MOTION). AS A RESULT OF THIS INCIDENT, THE COMPLAINT SAMPLE WAS USED TO BRING AWARENESS TO ALL APPLICABLE MANUFACTURING OPERATORS ON 04 APRIL 2011. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. A BATCH REVIEW WAS CONDUCTED FOR LOT 11C037 WHICH REVEALED A NON-CONFORMANCE AND RE-WORK RELATED TO THE REPORTED CONDITION. DURING RE-WORK OF THE LOT, SEVEN ADDITIONAL UNITS WERE IDENTIFIED AS HAVING A LEAK AT THE JUNCTION OF THE TUBING AND THE MICROBORE-Y. THE LOT WAS PLACED ON HOLD, AND AN INVESTIGATION WAS INITIATED WHICH DETERMINED THE ROOT CAUSE TO BE THE BONDING METHOD DURING MANUFACTURING. FOLLOWING RE-WORK ACTIVITIES, THE LOT MET ALL RELEASE ACCEPTANCE CRITERIA. THERE HAVE BEEN NO ADDITIONAL SIMILAR COMPLAINTS ASSOCIATED WITH LOT 11C037. CORRECTIVE ACTIONS WERE TAKEN TO RE-TRAIN MANUFACTURING PERSONNEL IN THE CORRECT METHOD FOR BONDING THE MICROBORE-Y AND TUBING. AS PART OF THE ROOT CAUSE INVESTIGATION, BAXTER WILL CONTINUE TO TRACK AND TREND COMPLAINTS ASSOCIATED WITH THE REPORTED CONDITION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR LEAKED FROM THE TUBING CONNECTION DURING PATIENT USE. THE DEVICE WAS FILLED WITH ROPIVACAINE HYDROCHLORIDE HYDRATE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE PATHWAY. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. THE SAMPLE IS AVAILABLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 11C037

    Patients

    Seq Age Sex Outcome Treatment
    1 ROPIVACAINE HYDROCHLORIDE HYDRATE